Events

Rappel de Fisher & Paykel Bubble CPAP Starter Kits

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Fisher & Paykel Healthcare SA de CV.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    16543
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • Cause
    Manufacturer has received customer reports relating to certain lot numbers of certain models of the nasal cpap prongs detaching from the fph flexitrunk nasal tubing., fph introducred a new version of nasal cpap prongs in 2013 and the lot numbers and models incorporate this new version. since the release of this new version fph has received reports of the affected prongs detaching from the nasal tubing during use especially in the presence of mucous and/ or moisture.
  • Action
    Product to be destroyed

Device

Fisher & Paykel Bubble CPAP Starter Kits

Manufacturer

Fisher & Paykel Healthcare SA de CV